Devices
Fresenius Kabi USA has initiated a mandatory “field action” software update for its Alyx Component Collection System because of an issue identified when the Alyx instrument is used for the red blood cell (RBC)/plasma procedure. “Pre-leukoreduced RBC volumes as low as 172 mL for a 200 mL target
Drugs
Rep. Frank Pallone, Jr. (D-NJ) has introduced the National Centers of Excellence in Continuous Manufacturing Act of 2018, which would allow FDA to partner with universities across the country to designate them as National Centers of Excellence in Continuous Pharmaceutical Manufacturing. He announced the bill’s introduction during a
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases.” The document provides recommendations for designing, developing, and establishing analytical performance for NGS-
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff.” The document describes how publicly accessible databases of human genetic variants
Drugs
FDA has rescinded an Alkermes refuse-to-file letter issued late last month on its NDA for ALKS 5461 (buprenorphine and samidorphan) an investigational drug for adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies. In doing so, the agency has now accepted
Drugs
A new FDA pilot program aims to evaluate model-informed drug development (MIDD) approaches that could “improve clinical trial efficiency, increase the probability of regulatory success, and optimize drug dosing/therapeutic individualization in the absence of dedicated trials,” according to an agency notice. As part of the 2017 renegotiated drug
FDA Policy/General
Panel to Review Siga Tech Smallpox NDA Federal Register notice: FDA announces a 5/1 Antimicrobial Drugs Advisory Committee meeting to discuss a Siga Technologies NDA for tecovirimat. 04/13/2018 Info Collection Extension on Dispute Resolution Federal Register notice: FDA submits for OMB approval an information collection extension for
Drugs
FDA has released the FDA-483 issued following a 5/22-26/17 and 5/29-6/2/17 inspection at the Celltrion drug manufacturing facility in Incheon, Korea. The 12 inspection observations were: * · failing to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed;
Drugs
FDA has finalized a guidance on Special Protocol Assessment (SPA) that provides drug manufacturers with information about the procedures and policies adopted by CDER/CBER for reaching an agreement on the design and size of certain clinical trials that could support marketing approval. “An SPA agreement indicates concurrence by the
FDA Policy/General
Federal Register notice: FDA has announced a 5/1 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Siga Technologies NDA for tecovirimat for the proposed indication of treating smallpox disease caused by variola virus in adults and pediatric patients. The product was developed under the agency’
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for its “Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice” (OMB Control Number 0910-0563). FDA regulations direct it to have adequate dispute resolution procedures to provide
Devices
FDA has released a final guidance on “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices.” The document describes agency recommendations for complying with the performance standard requirements for ultrasonic diathermy devices in 21 CFR 1050.10 where a manufacturer has otherwise complied with certain International Electrotechnical
Devices
A state court jury in New Jersey has handed down a $33 million verdict against C.R. Bard in a product liability lawsuit involving its allegedly defective pelvic mesh implants. Numerous pelvic-mesh related lawsuits are consolidated in the state, according to Courtroom View Network (CVN). The Bergen County jury
FDA Policy/General
Federal Register notice: FDA has submitted to OMB for approval an information collection extension for “Notification of the Intent To Use An Accredited Person Under the Accredited Persons Inspection Program” (OMB Control Number 0910-0569). The notification is part of FDA’s voluntary third-party inspection program applicable to manufacturers
Drugs
FDA has alerted health care professionals about a recall of all non-expired products marketed as sterile made by Coastal Meds (Biloxi, MS) due to visible particles in some drug vials for injection. “Injection of a drug product containing particulate matter may result in serious and potentially life threatening adverse
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” The International Council for Harmonization addendum provides updates to the original 2000 guidance and it does not alter the scope of the original guidance, which outlines an approach
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 18 ANDAs from multiple applicants. The ANDA holders have notified the agency that the drug products are no longer marketed and requested that their approval be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 5/4 Reagan-Udall Foundation annual public meeting to discuss its activities and how it supports the agency. The meeting will include a panel discussion on the “Evolution of FDA Science and Engagement” and the role of the Foundation. To view the notice,
Drugs
Premier Pharmacy Labs has recalled several lots of morphine sulfate, hydromorphone HCl and neostigmine methylsulfate due to a potential lack of sterility assurance. An FDA recall notice says that microbial contamination was detected during routine testing of subsequent unreleased product lots “due to interaction between the product syringe and tamper
Devices
FDA has approved a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants. Approval was based on data from the INSPIRE Trial, the first and largest controlled clinical organ preservation trial in lung transplantation that was conducted at 21 leading international academic institutions,
Drugs
Three Harvard Medical School researchers say that four years of experience with the FDA breakthrough therapy designation program indicate that while it has accelerated approval of some important drugs, the term “breakthrough designation” itself can be misleading to patients and healthcare providers. They suggest that Congress or FDA consider modifying
Drugs
FDA reportedly has opened a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine. Kaiser Health News reports that professor William Halford, who died 6/2017, injected subjects with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and